Unassociated Document


    EXHIBIT
      10.1

    


    Other
      Transactions (OT) Agreement/Modification 

    OTHER
      TRANSACTION FOR PROTOTYPE AGREEMENT

    DRAFT

    


    BETWEEN

    


    GenVec,
      Inc.

    65
      West
      Watkins Mill Road

    Gaithersburg,
      MD 20878

    


    AND

    


    The
      Department of Homeland Security 

    Science
      & Technology Directorate

    Washington,
      DC 20528

    


    
      	
              Agreement
                Number:

            	
              HSHQDC-07-9-00004

            
	
              Modification
                Number:

            	
              P00001

            
	
              Concerning:
                

            	
              Human
                Adenovirus Type C, Serotype 5

            


    

    Replication
      Deficient Foot-and-Mouth Disease (FMD) Serotype-Specific Vectored Vaccines,
      and
      Vectored Biological Immunomodulators

    


    
      	
              Base
                Period:

            	 
	
              Total
                Value of Base Period:

            	
              $5,976,726

            
	
              GenVec’s
                Cost Share/Contribution:

            	
              $0.00

            
	
              Government’s
                Cost Share/Contribution:

            	
              $5,976,726

            
	
              Funds
                Obligated:

            	
              $5,976,726

            
	 	 
	
              Option
                1:

            	 
	
              Total
                Value of Option 1:

            	
              $5,613,815

            
	
              GenVec’s
                Cost Share/Contribution:

            	
              $0.00

            
	
              Government’s
                Cost Share/Contribution:

            	
              $5,613,815

            
	
              Funds
                Obligated:

            	
              $5,613,815

            
	
              PR
                Number:

            	
              RSCB-07-00200

            
	
              Line
                of Accounting: 

            	
              NONE000-000-7X-31-01-0
                1-002-01-00-0000-00-00-00-0 0-GE-OE-25-11-000000

            
	 	 
	
              Option
                2:

            	 
	
              Total
                Value of Option 2:

            	
              $6,588,176

            
	
              GenVec’s
                Cost Share/Contribution:

            	
              $0.00

            
	
              Government’s
                Cost Share/Contribution:

            	
              $6,588,176

            
	
              Funds
                Obligated:

            	
              $0.00

            
	
              PR
                Number:

            	
              TBD

            
	
              Line
                of Accounting: 

            	
              TBD

            


    

    


    *
      The
      asterisk denotes that confidential portions of this exhibit have been omitted
      in
      reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
      portions have been submitted separately to the Securities and Exchange
      Commission.


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    


    Authority: Section
      831 of the Homeland Security Act of 2002, Public Law 107-296 The
      Modification of the Agreement is entered into between the United States of
      America, hereinafter
      called the Government, represented by The Department of Homeland Security
      (DHS), and GenVec, Inc., pursuant to and under US Federal law.

    


    
      	
              FOR
                GenVec:

            	 	
              FOR
                DHS:

            
	 	 	 
	
              /s/
                Douglas J. Swirsky

            	 	
              /s/
                Timothy B. Davis

            
	
              GenVec/Date

            	 	
              OT
                Agreements Officer/Date

            


    

    


    *
      The
      asterisk denotes that confidential portions of this exhibit have been omitted
      in
      reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
      portions have been submitted separately to the Securities and Exchange
      Commission.

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    The
      following articles are revised as follows:

    


    ARTICLE
      II: TERM
      is
      amended to add the following:

    


    The
      period of performance of Option 2 of this agreements starts on date of award
      and
      ends on 28 February 2010. 

     

    ARTICLE
      III: STATEMENT OF OBJECTIVES
      is
      revised to incorporate the following tasks for Option 2:

    


    I.
      Background

    


    The
      Department of Homeland Security (DHS) is committed to using cutting edge
      technologies and scientific talent in its quest to make America safer. DHS’s
      Directorate of Science & Technology (S&T) is tasked with researching and
      organizing the scientific, engineering, and technological resources of the
      United States and leveraging these existing resources into technological tools
      to help protect the homeland. In support of this effort, the DHS S&T Plum
      Island Animal Disease Center (PIADC) in Long Island, NY, is a unique research
      facility and critical national asset conducting research on diseases of
      livestock to protect America from terrorist threats directed against agriculture
      from the intentional introduction of diseases. As defined in Homeland Security
      Presidential Directive-7 (HSPD-7) and HSPD-9, the Secretary of Homeland Security
      is responsible for coordinating the overall national effort to enhance the
      protection of the critical infrastructure and key resources of the United
      States, including the defense of agriculture and food. To fulfill these
      requirements, DHS S&T supports programs at PIADC to strengthen the nation’s
      ability to predict and respond to the incursion of a foreign animal disease.
      

    


    DHS
      S&T requires scientific, vaccine development and regulatory services from
      GenVec, Inc. (GenVec). GenVec is a non-traditional contractor that has core
      competencies in patent protected technology platforms for replication-defective
      recombinant adenovirus serotype 5(rAd5) based-vaccines and therapeutic product
      candidates. GenVec’s technology has been successfully applied to discovery,
      pre-clinical, and clinical (Phase I-II) trials for human vaccines. GenVec also
      has experience in Ad5 production (scale-up and downstream processing) with
      an
      integrated QA program.

     

    GenVec
      has held a historical contractual scientific relationship with the USDA ARS
      on a
      Foot-and-Mouth Disease Virus (FMDV) countermeasure R&D program.
      Specifically, USDA and GenVec entered into Specific Cooperative Agreements
      (SCAs) in 2004-2005 and 2005-2006 to use reasonable commercial efforts to
      construct, produce and test a rAd5 based vector containing FMDV serotype empty
      capsids as part of a Plum Island FMD vaccine and immunomodulator program. These
      SCAs were funded through DHS-USDA interagency agreements and DHS S&T
      scientists have been involved in the testing and evaluation of several rAd5
      based vaccine vectors since 2005. In addition, USDA and GenVec have been
      interacting through a Collaborative Research and Development Agreement (CRADA)
      since 2004. The objective of the CRADA is to jointly construct and test GenVec
      Advectors expressing FMD genes and livestock cytokines, and to identify
      Advectors and complementing cell lines that have the potential to serve as
      a
      viral-vectored platform for a new generation of FMD vaccines. DHS S&T
      scientists have participated in the USDA-GenVec CRADA since 2004 through a
      DHS-USDA ARS interagency agreement on the joint research and development of
      FMD
      countermeasures, such as FMD vaccines and biological
      immunomodulators.

    


    *
      The
      asterisk denotes that confidential portions of this exhibit have been omitted
      in
      reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
      portions have been submitted separately to the Securities and Exchange
      Commission.

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    


    Based
      on
      the successful technical outcome to date of the base year contract agreement
      (awarded 1 February 2007) and the initiation and acceleration of pre-product
      development activities at GenVec (originally targeted for option year 1) that
      has resulted in the acceleration of lead FMD vaccine material for testing,
      DHS
      would like to move forward with GenVec and exercise option year 2 to allow
      uninterrupted continuation and development of the lead FMD vaccine candidate
      for
      eventual conditional product licensing * by USDA Center for Veterinary
      Biologics. These products would be made available for potential manufacture
      and
      procurement by the USDA National Center for Animal Health Emergency Management
      National Veterinary Stockpile to help accomplish critical mission objectives
      with regard to live FMDV and vaccine countermeasures against high consequence
      Foreign Animal Diseases such as those caused by FMDV. 

     

    II.
      Scope of Work

     

    For
      option year 2, no further work activities for milestone 1,*

    


    For
      option year 2, work activities for milestone 2, *

    


    For
      option year 2, work activities for milestone 3, *

    


    For
      option year 2, no further work activities for milestone 4, *

    


    For
      option year 2, milestone 5, *

     

    For
      option year 2, milestone 6 *

    


    For
      option year 2, work activities for milestones 7 *

    


    For
      option year 2, work activities for 8 from the original SOW *

    


    For
      option year 2, milestone 9 *

    


    For
      option year 2, milestone 10 *

    


    *
      The
      asterisk denotes that confidential portions of this exhibit have been omitted
      in
      reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
      portions have been submitted separately to the Securities and Exchange
      Commission.

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    For
      option year 2, a new milestone 11 has been added with the following work
      activities:

    
      	 	
              1.

            	
              *

            


    

    
      	 	
              2.

            	
              *

            


    

    
      	 	
              3.

            	
              *

            


    

    


    III.
      Deliverables.

    


    See
      Attachment II for detailed list and description of technical data and physical
      deliverables associated with each of the four revised milestones (milestones
      6,
      7, 9, and 10) and the new milestone (milestones 11).

     

    IV.
      Other Contract Details

    


    

        	
                A.

              	
                Period
                  of Performance. The period of performance for this
                  revised SOW is a base period from the contract year one option
                  award date
                  to February 28, 2010..  DHS may give subsequent
                  extension notices to GenVec, Inc. in writing for further performance
                  in
                  accordance with the terms of this
                  SOW.

              



    

    



      
        	
                B.

              	
                Travel. All
                  travel must be approved by the DHS Technical Representative. All
                  foreign
                  travel must be approved in advance by the ORD Program Manager,
                  DHS
                  Programs, Plans and Budgets (PPB), and the DHS S&T Special Assistant
                  for International Policy.

              


      


    



      
        	
                C.

              	
                DHS-Furnished
                  Information. 

              


      


    



      
        	 	
                i.

              	
                DHS
                  will provide certain DHS information, materials, and forms unique
                  to DHS
                  to GenVec, Inc. to support certain tasks under this SOW. Delays
                  in the
                  supply of DHS information, materials to GenVec could result in
                  delays to
                  the completion of certain
                  deliverables.

              


      


    

        	 	
                ii.

              	
                The
                  DHS S&T Technical Representative identified in this SOW will be the
                  point of contact (POC) for identification of any required information
                  to
                  be supplied by DHS.

              



    


      
        	 	
                iii.

              	
                GenVec,
                  Inc. will prepare any documentation according to the
                  guidelines provided by DHS.

              


      


    


    
      	E.	
              Place
                of Performance. GenVec,
                Inc. will
                perform the work under this SOW at their place of R&D business,
                located in Gaithersburg, MD and through the use of sub-contractors
                where
                required as identified in this SOW.

            


    

    


    
      	F.	
              DHS-Furnished
                Property.
                DHS property will not be provided to GenVec, Inc. unless
                otherwise agreed to by the parties of the agreement.
                

            


    

    


    
      	G.	
              Deliverables.
                GenVec, Inc. will
                provide all deliverables identified in this SOW directly to the DHS
                S&T Technical Representative with a copy of the transmittal letter
                to
                the Other Transaction Contracting Officer and as otherwise specified
                in
                this SOW.

            


    

    


    *
      The
      asterisk denotes that confidential portions of this exhibit have been omitted
      in
      reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
      portions have been submitted separately to the Securities and Exchange
      Commission.

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    


    
      	H.	
              Publications.
                All manuscripts must be approved prior to submission by the DHS S&T
                Technical Representative at PIADC and by the GenVec Technical
                Representative with approval not to be unreasonably withheld by either
                party. 

            


    

    


    
      	I.	
              Program
                Status Report. GenVec,
                Inc. will
                deliver a quarterly program status reports to the DHS S&T Technical
                Representative and DHS S&T Resource Manager containing the following
                metrics: (1) monthly scientific reports will be delivered to the
                DHS
                S&T Technical Representative according to mutually agreed upon format
                and content requirements; and (2) a monthly report, including financial,
                schedule, and scope information, risk information and an assessment
                of
                performance will be delivered to the DHS S&T Technical Representative
                and the DHS S&T Resource Manager. Financial data should include
                monthly expenditures for labor, travel and
                equipment.

            


    

    


    
      	J.	
              Security
                Requirements.
                All work performed under this SOW is unclassified unless otherwise
                specified by DHS. If classified work is required under this SOW,
                DHS will
                provide specific guidance to the contractor as to which work will
                be
                conducted in a classified manner and at which classification level.
                GenVec, Inc. participants
                will also adhere to applicable government orders, guides, and directives
                while performing the work hereunder.


            


    

    


    V.
      Points of Contact

    


    GenVec,
      Inc. Points
      of
      Contact (POCs) are as follows:

    


    
      	 	
              ·

            	
              Technical
                POC(s) – 

            


    

    *

    65
      West
      Watkins Road

    Gaithersburg,
      MD 20878

    Phone
      :
      *

    


    
      	 	
              ·

            	
              Financial
                POC(s) – 

            


    

    *

    65
      West
      Watkins Road

    Gaithersburg,
      MD 20878

    Phone:
      *

    


    *
      The
      asterisk denotes that confidential portions of this exhibit have been omitted
      in
      reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
      portions have been submitted separately to the Securities and Exchange
      Commission.


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    


    The
      DHS
      POCs are as follows:

    


    
      	 	
              ·

            	
              DHS
                S&T Technical Representative –

            


    

    *

    Branch
      Chief for Agricultural Security

    Director
      for Joint Agro Defense Office (JADO)

    Science
      & Technology

    Department
      of Homeland Security

    Washington,
      DC 20528

    Voice:
      *

    Fax:
      *

    Mobile:
      *

    Email:
      *

     

    
      	 	
              ·

            	
              Resource
                Manager 

            


    

    *

    Department
      of Homeland Security

    ATTN:
      Science and Technology Directorate/Office,
      *

    Washington,
      DC 20528

    *

    *

     

    Either
      party may change its representatives named in this Statement of Work by written
      notification to the other Party. The Government will effect the change as stated
      in subparagraph C.4 of Article IV of the Other Transaction Agreement.


     

    *
      The
      asterisk denotes that confidential portions of this exhibit have been omitted
      in
      reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
      portions have been submitted separately to the Securities and Exchange
      Commission.

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    ATTACHMENT
      I – STATEMENT OF WORK EXECUTION (Option Year 2 Funded
      Milestones)

    


    Milestone
      2: *

    


    General
      Approach

    


    *

     

    Milestone
      3: *

    


    General
      Approach

    


    *

    Milestone
      6: *

    


    General
      Approach

    


    *

    


    Milestone
      7: *

    


    General
      Approach

    


    *

    


    Milestone
      9: *

    


    General
      Approach

    


    *

    


    Milestone
      11: *

    


    General
      Approach

    


    *

    


    *
      The
      asterisk denotes that confidential portions of this exhibit have been omitted
      in
      reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
      portions have been submitted separately to the Securities and Exchange
      Commission.

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    LIST
      OF
      TECHNICAL DELIVERABLES

    (BASE
      AGEEMENT, OPTION YEAR ONE, AND OPTION YEAR TWO)

     

    
      
        
          	
                  Milestone

                	 	
                  Deliverables

                	 	
                  *

                	 	
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                  *

                	 	
                  Timeline

                
	
                  
                    Milestone
                      1 

                  

                	 	
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    *
      The
      asterisk denotes that confidential portions of this exhibit have been omitted
      in
      reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
      portions have been submitted separately to the Securities and Exchange
      Commission.

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      
        
          	
                  Milestone
                    1 - continued

                	 	
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                  Milestone
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    *
      The
      asterisk denotes that confidential portions of this exhibit have been omitted
      in
      reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
      portions have been submitted separately to the Securities and Exchange
      Commission.

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      
        	
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                Milestone
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                Milestone
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                Milestone
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                Milestone
                  9

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    *
      The
      asterisk denotes that confidential portions of this exhibit have been omitted
      in
      reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
      portions have been submitted separately to the Securities and Exchange
      Commission.


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      
        	
                Milestone
                  10

              	 	
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                *

              	 	
                *

              	 	
                *

              


      

    

    *
      The
      asterisk denotes that confidential portions of this exhibit have been omitted
      in
      reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
      portions have been submitted separately to the Securities and Exchange
      Commission.


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    OPTION
      YEAR 2 – MILESTONE DELIVERABLES, BUDGET and PAYMENT SCHEDULE

    


    
      	
              Milestone

            	 	
              Budget

            	
               

            	
              Payment Schedule

            	
               

            
	
              2-
                *

            	 	 	
              
              

              *

            	 	 	
              
              

              *

            	 
	
              3-
                *

            	 	 	
              *

            	 	 	
              *

            	 
	
              6-
                *

            	 	 	
              
              

              *

            	 	 	
              
              

              *

            	 
	
              7-
                *

            	 	 	
              *

            	 	 	
              *

            	 
	
              8-
                *

            	 	 	
              *

            	 	 	
              *

            	 
	
              9- *

            	 	 	
              
              

              *

            	 	 	
              *

            	 
	
              10-
                *

            	 	 	
              
              

              *

            	 	 	
              
              

              *

            	 
	
              11-
                *

            	 	 	
              *

            	 	 	
              *

            	 
	
              TOTAL
                OPTION YEAR 2

            	 	 	
              6,588,176

            	 	 	
              6,588,176

            	 


    

    


    *
      The
      asterisk denotes that confidential portions of this exhibit have been omitted
      in
      reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
      portions have been submitted separately to the Securities and Exchange
      Commission.